ClearanceBrief
Panels › Cardiovascular › Product code LIT · Class 2

Catheter, Angioplasty, Peripheral, Transluminal

Regulation 870.1250

5510(k)s in 12 months (405 all time)
2recalls in 12 months (32 all time)
28recalls that name a 510(k)
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Top companies in LIT

Company510(k)sRecalls
Boston Scientific528
Cordis Corp.306
Meadox Medicals, Div. Boston Scientific Corp.140
Vas-Cath, Inc.140
C.R. Bard, Inc.130
Cook Incorporated130
Scimed Life Systems, Inc.130
Advanced Cardiovascular Systems, Inc.100
Biotronik AG100
Ev3, Inc.73
Decided510(k)Device and applicantCode
Sep 21, 2026K260416ZYLOX Hippo PTA Balloon Dilatation Catheter
Zylox Medtech Co., Ltd., CN
LIT
Sep 16, 2026K254212NC PTA Balloon Dilatation Catheter
Kossel Medtech (Suzhou) Co., Ltd., CN
LIT
May 20, 2026K260304WAVE PTA Balloon Catheter
WAVE Medical AG, CH
LIT
Feb 13, 2026K252512Armada™ 14 NC PTA Catheter
ABBOTT MEDICAL
LIT
Dec 18, 2025K251915Amethyst HP PTA OTW 0.035 Catheter
Natec Medical , Ltd., MU
LIT
Apr 4, 2025K250706Passeo-35 Xeo Peripheral Dilatation Catheter; Passeo-18 Peripheral Dilatation Catheters; Passeo-14 Peripheral Dilatation
Biotronik, Inc.
LIT
Feb 27, 2025K243704Parafleet SC 014 PTA Balloon Dilatation Catheter; Parafleet SC 018 PTA Balloon Dilatation Catheter; Parafleet SC 035 PTA
Brosmed Medical Co., Ltd., CN
LIT
Dec 18, 2024K241040Amethyst HP PTA OTW 0.035 Catheter
Natec Medical , Ltd., MU
LIT
Nov 15, 2024K242419018 Hydrophilic Coated OTW PTA Balloon Dilatation Catheter
Creagh Medical Ltd. Dba Surmodics, Inc., IE
LIT
Jul 16, 2024K241740Finesse Injectable™ PTA Balloon Dilatation Catheter
Summa Therapeutics
LIT
Jul 11, 2024K241711Oscar Peripheral Multifunctional Catheter system
Biotronik, Inc.
LIT
Jul 10, 2024K241683Sterling™ MONORAIL™ PTA Balloon Dilatation Catheter (H74939031404020 ); Sterling™ MONORAIL™ PTA Balloon Dilatation Cathe
Boston Scientific Corporation
LIT
Jun 11, 2024K241025JADE PLUS PTA Balloon Dilatation Catheter
OrbusNeich Medical (Shenzhen) Co., Ltd., CN
LIT
Dec 20, 2023K231402HP PTA Balloon Dilatation Catheter
Kossel Medtech (Suzhou) Co., Ltd., CN
LIT
May 26, 2023K230263Finesse™ Injectable PTA Balloon Dilatation Catheter
Summa Therapeutics, LLC
LIT
Apr 5, 2023K214009D·Kaptain PTA High Pressure Balloon Dilatation Catheter
Dk Medical Technology Co., Ltd., CN
LIT
Mar 22, 2023K230191Arise™ UHP Dilatation Catheter
Creagh Medical, Ltd., IE
LIT
Feb 16, 2023K222065Passeo-35 Xeo Peripheral Dilatation Catheter
Biotronik, Inc.
LIT
Jan 20, 2023K223177Highlander™ 014 PTA Balloon Dilatation Catheter
C.R. Bard, Inc.
LIT
Dec 14, 2022K221245PTA Balloon Dilatation Catheter
Kossel Medtech (Suzhou) Co., Ltd., CN
LIT
Sep 2, 2022K221414ENROUTE Enflate Transcarotid RX Balloon Dilatation Catheter
Silk Road Medical, Inc.
LIT
Aug 22, 2022K221832SABER .014 PTA Dilatation Catheter; SABERX .014 PTA Dilatation Catheter
Cordis US Corp
LIT
Jul 19, 2022K212215Tiche PTA Balloon Dilatation Catheter
Brosmed Medical Co., Ltd., CN
LIT
Jul 6, 2022K214038Oscar Peripheral Multifunctional Catheter system
Biotronik, Inc.
LIT
Jun 29, 2022K220410Ebony HP PTA OTW 0.035 Catheter
Natec Medical , Ltd., MU
LIT
Jun 9, 2022K221339Paladin Carotid Post-Dilation Balloon System with Integrated Embolic Protection
Contego Medical, Inc.
LIT
May 5, 2022K221057Viatrac 14 Plus Peripheral Dilatation Catheter
Abbott Vascular
LIT
Dec 15, 2021K213631Chocolate PTA Balloon Catheter
Medtronic, Inc.
LIT
Aug 3, 2021K201246PTA Balloon Catheter (PVQ), MIT PTA Balloon Catheter (PVQ)
Qualimed USA, LLC
LIT
Jun 16, 2021K211044Sublime Radial Access 018 RX Dilatation Catheter
Creagh Medical Ltd. (A Wholly Owned Subsidiary of Surmodics,, IE
LIT
Apr 23, 2021K210626SABER .035 Percutaneous Transluminal Angioplasty (PTA) Dilatation Catheter
Cordis Corporation
LIT
Dec 10, 2020K202231JADE
OrbusNeich Medical (Shenzhen) Co., Ltd., CN
LIT
Nov 18, 2020K202800Pacific Plus PTA Catheter
Medtronic Vascular,Inc(Formerly D.B.A Ev3 Inc.,Covidien, LLC)
LIT
Oct 9, 2020K201377SABERX RADIANZ Percutaneous Transluminal Angioplasty Dilatation Catheter
Cordis Corporation
LIT
Sep 15, 2020K201170Athletis PTA Balloon Dilatation Catheter
Boston Scientific Corporation
LIT
Sep 11, 2020K201333SABER .035 PTA Dilatation Catheter
Cordis Corporation
LIT
Jul 28, 2020K201794Jade
OrbusNeich Medical (Shenzhen) Co., Ltd., CN
LIT
May 20, 2020K192399Infinity Angioplasty Balloon Catheter
Infinity Angioplasty Balloon Company, LLC
LIT
May 14, 2020K200700Surmodics Sublime Radial Access 014 RX PTA (Percutaneous Transluminal Angioplasty) Dilatation Catheter
Creagh Medical, Ltd., IE
LIT
Jan 15, 2020K191275All’InCath 035M PTA Balloon Dilatation Catheter
Nexstep Medical, FR
LIT
Nov 26, 2019K192907Advocate PTA Catheter
Merit Medical Systems, Inc., IE
LIT
Oct 24, 2019K190037Cronus HP PTA Balloon Catheter
Nipro Medical Corporation
LIT
Oct 3, 2019K192318Ultraverse 014 and 018 PTA Balloon Dilatation Catheters
Bard Peripheral Vascular, Inc.
LIT
Apr 23, 2019K190753EverCrossTM 0.035 OTW PTA Dilatation Catheter
Medtronic, Inc. (Formerly D.B.A. Ev3, Inc. Covidien, LLC.)
LIT
Dec 6, 2018K181529Vanguard IEP Peripheral Balloon Angioplasty System with Integrated Embolic Protection
Contego Medical, LLC
LIT
Sep 6, 2018K181128Paladin Carotid Post-dilation Balloon System with Integrated Embolic Protection (Paladin System)
Contego Medical, LLC
LIT
Aug 3, 2018K181323Atlas Gold PTA Dilatation Catheter
C.R. Bard, Inc.
LIT
Apr 19, 2018K180007018 Hydrophilic Coated OTW PTA Balloon Dilatation Catheter
Creagh Medical, Ltd., IE
LIT
Apr 12, 2018K173515Admiral Xtreme
Medtronic Vascular
LIT
Feb 9, 2018K173894Jade PTA Balloon Dilatation Catheter
Orbusneich Medical Trading, Inc.
LIT

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